A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea

ovartis Vaccines and Diagnostics0 sites750 target enrollmentDecember 10, 2014

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
Sponsor: ovartis Vaccines and Diagnostics
Enrollment: 750
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

December 10, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Vaccines and Diagnostics

•1\.Male and female children, 2 months to 5 years of age, who are scheduled to receive vaccination to prevent Haemophilus influenzae type b
•2\.Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
•3\.After the nature of the study has been explained according to local regulatory requirements, documented informed consent from parent(s) and/or legally authorized caretaker(s) of the child
•4\.Ability to comply with all study procedures and follow\-up as scheduled in the study protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 750
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\.The Investigator and research staff should review the Vaxem™Hib vaccine Korean Prescribing information to verify that no contraindications, special warnings and/or precautions are indicated for any subject prior to enrolment.